Even though the FDA has not approved any follow-on versions of Sanofi-Aventis’s anticoagulant Lovenox (Enoxaparin), lawyers for generics makers have disclosed that they will seek monetary damages in an antitrust case if they win a patent infringement suit.
Sanofi-Aventis is seeking to overturn a district court decision that found two of its patents invalid due to inequitable conduct. The case involves whether Sanofi-Aventis knowingly misled USPTO when comparing Lovenox’s half-life to the prior art.
Amphastar and Teva are alleging that Sanofi-Aventis compared Lovenox to another drug at a different dose, when their drug would have had the same half life if it had been compared at the same dosage, according to Amphastar’s attorney Jan Weir.
This is the second time that Sanofi-Aventis and generics makers Amphastar and Teva are appearing in front of the Federal Circuit. Sanofi-Aventis has already lost twice in the district court of California - first in a summary judgment ruling and again in a jury trial.
Weir, a shareholder at law firm Stradling Yocca Carlson & Rauth, noted that the Federal Circuit has already upheld the half life issue as ”highly material” to the case, and is now deciding on the question of whether Sanofi-Aventis intentionally defrauded the patent office.
Neither Sanofi-Aventis nor an attorney responded to a request for comment.
Weir noted that Amphastar’s abbreviated new drug application for generic enoxaparin, a protein-based drug, is still pending. Yet he noted that the clock on the 180-day period of exclusivity won’t begin to run until its product is approved.
In addition, if the district court ruling is upheld, attorneys for Teva and Amphastar will proceed with an antitrust case against Sanofi-Aventis, Weir said, which would mean that the innovator company could be on the hook for monetary damages.
”There are substantial penalties in the antitrust case,” he said. ”It’s an important case, in that the patent office relies on the data that companies submit to them.”
He cited as precedent the Supreme Court case of Walker Process v. Food Machinery, which held that a company can be prosecuted under the Sherman Act if it used a fraudulently obtained patent to maintain a monopoly.
He noted that if Amphastar prevails in the antitrust case, damages will be ”automatically trebled.”
The Federal Circuit heard arguments in January, and a decision could take anywhere from two to eight months, according to Aaron Barkoff, a partner at law firm McDonnell Boehnen Hulbert & Berghoff, who is not involved in the case.
While not commenting on the strength of Amphastar’s argument, Barkoff suggested that the generics maker, which is based in California, might have an advantage since the case is being heard in the company’s backyard.
Momenta Pharmaceuticals and partner Sandoz are also trying to develop a generic version of Lovenox, and a decision in favor of Amphastar could benefit them as well, Barkoff noted. Yet he added that Momenta will need to wait until after Amphastar’s marketing exclusivity ends before launching its product.
Momenta received a non-approvable letter for its follow-on protein product in November after the FDA required that the company submit more immunogenicity data. The decision raised questions about whether the agency is ready to approve a bio-similar product before a regulatory pathway is in place.
Lovenox had sales of USD 2.88bn in the first nine months of last year, achieving double-digit growth in some markets. Its patent expires in 2012. (source:www.pharmawire.com)
Sanofi-Aventis is seeking to overturn a district court decision that found two of its patents invalid due to inequitable conduct. The case involves whether Sanofi-Aventis knowingly misled USPTO when comparing Lovenox’s half-life to the prior art.
Amphastar and Teva are alleging that Sanofi-Aventis compared Lovenox to another drug at a different dose, when their drug would have had the same half life if it had been compared at the same dosage, according to Amphastar’s attorney Jan Weir.
This is the second time that Sanofi-Aventis and generics makers Amphastar and Teva are appearing in front of the Federal Circuit. Sanofi-Aventis has already lost twice in the district court of California - first in a summary judgment ruling and again in a jury trial.
Weir, a shareholder at law firm Stradling Yocca Carlson & Rauth, noted that the Federal Circuit has already upheld the half life issue as ”highly material” to the case, and is now deciding on the question of whether Sanofi-Aventis intentionally defrauded the patent office.
Neither Sanofi-Aventis nor an attorney responded to a request for comment.
Weir noted that Amphastar’s abbreviated new drug application for generic enoxaparin, a protein-based drug, is still pending. Yet he noted that the clock on the 180-day period of exclusivity won’t begin to run until its product is approved.
In addition, if the district court ruling is upheld, attorneys for Teva and Amphastar will proceed with an antitrust case against Sanofi-Aventis, Weir said, which would mean that the innovator company could be on the hook for monetary damages.
”There are substantial penalties in the antitrust case,” he said. ”It’s an important case, in that the patent office relies on the data that companies submit to them.”
He cited as precedent the Supreme Court case of Walker Process v. Food Machinery, which held that a company can be prosecuted under the Sherman Act if it used a fraudulently obtained patent to maintain a monopoly.
He noted that if Amphastar prevails in the antitrust case, damages will be ”automatically trebled.”
The Federal Circuit heard arguments in January, and a decision could take anywhere from two to eight months, according to Aaron Barkoff, a partner at law firm McDonnell Boehnen Hulbert & Berghoff, who is not involved in the case.
While not commenting on the strength of Amphastar’s argument, Barkoff suggested that the generics maker, which is based in California, might have an advantage since the case is being heard in the company’s backyard.
Momenta Pharmaceuticals and partner Sandoz are also trying to develop a generic version of Lovenox, and a decision in favor of Amphastar could benefit them as well, Barkoff noted. Yet he added that Momenta will need to wait until after Amphastar’s marketing exclusivity ends before launching its product.
Momenta received a non-approvable letter for its follow-on protein product in November after the FDA required that the company submit more immunogenicity data. The decision raised questions about whether the agency is ready to approve a bio-similar product before a regulatory pathway is in place.
Lovenox had sales of USD 2.88bn in the first nine months of last year, achieving double-digit growth in some markets. Its patent expires in 2012. (source:www.pharmawire.com)
